Sub-Saharan Africa has about 10% of the world's population, but was home to more than 60% of all people living with HIV in 2003. South Africa continues to have the largest number of people living with HIV in the world, and as in other parts of sub-Saharan Africa, heterosexual exposure is the primary HIV transmission category. Worldwide, efforts to stem the spread of HIV among heterosexuals have stressed the impact of HIV on women. Oft-cited statistics indicate that about half of all people living with HIV are women. The strategies typically offered to address the impact of HIV on women are interventions with women.

To be sure, there is an alternative approach to addressing women's risk of heterosexual transmission of HIV, one that would be an important complement to the predominant approach: namely, focusing on men. By reducing men's sexual risk behavior, it should be possible to reduce rates of HIV in both men and women. Men's rates would decline because they are the recipients of the intervention; women's rates would decline because they have sex with men. Interventions aimed at men could take into account the power that men have in sexual decision-making and risk taking. However, whether one considers the US literature or the international literature, few randomized controlled trials of HIV/STD risk-reduction interventions have focused on heterosexual men.

Accordingly, the purpose of this research is to develop and test the efficacy of an intervention to curb HIV/STD risk-associated behavior in South African men who have sex with women. A cluster-randomized control trial design will be used to reduce the potential for contamination between treatment arms that would be present if individuals were randomized. An attention control group will be used to control for Hawthorne effects, special attention, and group interaction. Matched pairs of neighborhoods in Black townships in Eastern Cape Province, South Africa similar on key characteristics will be created, 22 pairs will be randomly selected, and men will be recruited. One neighborhood in each pair will be randomly assigned to each of the 2 study arms.

The primary hypothesis is that men who receive a culturally appropriate theory-based HIV/STD risk-reduction intervention will be more likely to report consistently using condoms during vaginal intercourse in the 12-month post intervention period than will men who receive an attention-control intervention, controlling for baseline condom use.

Men who reported at least 1 vaginal intercourse act in the past 3 months and whose number of reported condom-protected vaginal intercourse acts equaled their number of vaginal intercourse acts were coded as practicing consistent or 100% condom use. Men who reported at least 1 vaginal intercourse act and whose reported number of condom-protected vaginal intercourse acts was less than their number of vaginal intercourse acts were coded as not practicing consistent condom use. Separate binary variables reflected consistent condom use with primary partners and casual partners.

Men who reported at least 1 vaginal intercourse act in the past 3 months and whose number of reported condom-protected vaginal intercourse acts equaled their number of vaginal intercourse acts were coded as practicing consistent or 100% condom use. Men who reported at least 1 vaginal intercourse act and whose reported number of condom-protected vaginal intercourse acts was less than their number of vaginal intercourse acts were coded as not practicing consistent condom use. Separate binary variables reflected consistent condom use with primary partners and casual partners.

The proportion of condom-protected acts of vaginal intercourse is defined as the self-reported number of acts of vaginal intercourse in which the respondent used a condom in the past 3 months divided by the total number of acts of vaginal intercourse the respondent reported in the past 3 months. Calculated separately for steady and casual partners.

The proportion of condom-protected acts of vaginal intercourse is defined as the self-reported number of acts of vaginal intercourse in which the respondent used a condom in the past 3 months divided by the total number of acts of vaginal intercourse the respondent reported in the past 3 months. Calculated separately for steady and casual partners.

Behavioral: Men Making a Difference HIV/STD Risk Reduction Intervention

Developed based on social cognitive theory and extensive formative research, Men Together Making a Difference HIV/STD risk-reduction intervention consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet).

Other Name: HIV/STD Risk Reduction Intervention

Active Comparator: Health Promotion Control

Behavioral: Health Promotion Control

The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01490359

Sponsors and Collaborators

University of Pennsylvania

University of Fort Hare

Temple University

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)